a study of the effects of oxytocin in adults with obesity and binge-eating disorder

Conditions: Binge-eating Disorder

Summary: this study evaluates the impact of intranasal oxytocin vs placebo in patients with obesity and binge eating disorder with obesity. we hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[weight loss, reduction in bingeing frequency\], and have a satisfactory safety and tolerability profile. we will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention

study staff will screen patients for eligibility as per eligibility criteria. at least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. all other study staff and test subjects will be blinded. study subject medical histories, physical exams, anthropometric measurements, labs, ekg's, and eating habits will be monitored over 8 weeks. subjects will be evaluated at the following intervals: baseline, week 2, week 4, and week 8.

Eligibility criteria:
inclusion criteria: * males and females, 18-45 years old * bmi 30-50 kg/m2 * bed as assessed by structured clinical interview for dsm-5 disorders (scid-5-rv) exclusion criteria: * substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results * medication changes within 4 weeks of baseline visit * use of prescription or over-the-counter drugs or dietary/herbal supplements for weight loss (e.g., lorcaserin, phentermine, topiramate, liraglutide). metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months * history of any of the following medical conditions: inflammatory bowel disease; bariatric surgery (except for those participants with a history of laparoscopic adjustable gastric band surgery); epilepsy; untreated thyroid disease * history of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged qt * hematocrit \>2% below normal * hemoglobin a1c \>8% * alt or ast \>2.5 times upper limit of normal * glomerular filtration rate \< 60 ml/min * hyponatremia * pregnancy or breastfeeding * unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only) * history of psychosis or active suicidality as assessed by the scid-5-rv * weight change \>5 kg within 3 months prior to randomization * current smoking or tobacco use * participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization * any significant illness, condition, or medication that the investigator determines could interfere with study participation and impact data collection or patient safety

Keywords: obesity weight loss binge binge-eating disorder oxytocin overeating